NIH

Senator Elizabeth Warren (D-MA) recently introduced legislation that, if passed, would require certain pharmaceutical companies that enter into settlement agreements with the Department of Justice or other governmental...more

Personalized medicine has a friend in high places. President Obama recently announced an initiative to support “precision” or personalized medicine. In very general terms, the President stated during his 2015 State of the...more

In a move designed to stretch budget dollars and spread the research wealth, the National Institute of General Medical Sciences (NIGMS) announced last week that starting next year, it will impose a one-grant-at-a-time policy...more

On November 21, 2014, the National Institutes of Health (“NIH”) published a notice of proposed rulemaking regarding requirements for clinical trial registration and the reporting of results (“Notice” or “Proposed Rule”)....more

Like Canada, environmental contamination gets blamed for a lot of things wrong in America. But a recent study in a respected NIH journal, Environmental Health Perspectives, offers a novel expansion of what in our lives that...more

On Monday, Genetic Engineering and Biotechnology News (GEN) published a list of the Top 50 NIH-funded U.S. universities in fiscal year October 1st – September 30th. Geographically, California leads the list of most Federal...more

Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that...more

Even for those who carefully follow legal developments in the health care fraud arena, the Department of Health and Human Service’s Office of Research Integrity (“ORI”) is an agency that rarely appears on the radar. According...more

In this issue:
Implementation of the Affordable Care Act; Other Federal Regulatory Initiatives; Other Congressional and State Initiatives; and Hearings and Mark-Ups Scheduled.
Excerpt from Implementation of the...more

In This Issue:
Implementation of the Affordable Care Act; Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; and Hearings and Mark-Ups Scheduled.
Excerpt from...more

Last week, the National Institutes of Health denied a petition from a coalition of "public interest" groups who petitioned the agency to exercise so-called "march-in rights" under provisions of the Bayh-Dole Act against...more

In the early morning of October 1, 2013, the U.S. federal government officially went dark. The shutdown came in the aftermath of the Senate’s decisive vote to reject a House plan that would have kept the government funded for...more

Northwestern University will pay $2.93 million to settle a federal False Claims Act (FCA) lawsuit brought by a former employee who alleged Northwestern allowed a researcher to submit false claims under certain cancer research...more

On Wednesday, the National Institutes of Health (NIH) announced that the agency had reached an understanding with the family of Ms. Henrietta Lacks regarding access to genomic data for the HeLa cell line, which was derived...more

In a July 12, 2013 letter to Dr. Francis S. Collins of the National Institutes of Health (“NIH”), Senator Patrick J. Leahy urged the NIH to exercise its march-in rights under the Bayh-Dole Act to directly license the genetic...more